PMA
P810032: MODELS B-13F (P-10) & B-1H (P-11)
FDA PMA · Intraocular lens · Alcon Laboratories
Key facts
| PMA number | P810032 |
|---|---|
| Trade name | MODELS B-13F (P-10) & B-1H (P-11) |
| Generic name | Intraocular lens |
| Applicant | Alcon Laboratories |
| Owner/operator | Alcon Laboratories, Inc. |
| Product code | HQL |
| Approval date | Apr 23, 1982 |
| Docket number | 82M-0142 |
| Notice date | May 25, 1982 |
| Establishment registration | 1610287 |
| FEI number | 1610287 |
At a glance
- 10–99 Supplements
- Jun 20, 2024 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: